BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC - DURAHESIVE CONVEX WAFER

    MDR report key: 3884105 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00184
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. END-USER WAS PROVIDED INSTRUCTIONS IN SKIN CARE AND CRUSTING TECHNIQUES USING STOMAHESIVE POWDER AND A NON-STINK PROTECTIVE BARRIER WIPE. END-USER WAS ADVISED TO NOTIFY CONVATEC WITH ANY QUESTIONS OR CONCERNS. LASTLY, END-USE WILL BE SENT SAMPLES OF THE SENSI-CARE NO STING PROTECTIVE BARRIER WIPE AND STOMAHESIVE POWDER. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(6), 2014. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH 4A02332 WAS MADE ACCORDING TO SPECIFICATION. AFTER DETAILED BATCH REVIEW, NO DISCREPANCIES (INCLUDES NON-CONFORMANCES/DEVIATIONS) WERE FOUND. THIS COMPLAINT IS NOT ASSOCIATED WITH A PRODUCT MALFUNCTION. THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS AS A RESULT OF SKIN COMPLICATIONS WHICH ARE CAUSED BY A VARIETY OF EXTERNAL FACTORS NOT RELATED TO THE DESIGN, MATERIALS, AND/OR PROCESSES OF THE PRODUCT. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT END-USER DEVELOPED THREE (3) TO FOUR (4) AREAS OF EXCORIATED SKIN UNDER THE MASS OF THE OSTOMY WAFER WHICH FIRST APPEARED IN (B)(6), 2014. THE END-USER DESCRIBES THESE AREAS AS BEING RED TO BROWN IN COLOR WITH OCCASIONAL BLEEDING. TREATMENT OF ORAL ANTIBIOTICS PRESCRIBED BY A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335334 SUR-FIT NATURA 2 PC - DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 413181 4A02332

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention